GxP for Quality Management: By Kenn Milton
Inventory Management is the essence of Quality Management.
General Knowledge & Insights
Inventory Management is being in control of the company’s current products and services, systems and tools, which are supporting the business operations. It is from the Inventory Management that all other processes originate. Implementing inventories in a Quality Management System will ensure that your company can run projects in a controlled environment. Supporting processes are initiated to maintain the Inventory in a state, that is fit-for-intended-use and documented information is written, approved and stored to provide objective documented evidence of the actions during the entire system life cycle. Succesful Inventory Management is therefore the base for Quality Management.
Sustainable Inventory Management is one of the most important parts of running a business effectively and perhaps one of the sole reasons for Quality Management. If the business does not have an inventory, the business has nothing to sell.
The goal in Inventory Management is to continously be able to introduce new innovative products and services to the market and maintain these products and services, while obtaining a competitive advantage. To do this, the business must establish effective processes that can contribute to the strategic direction.
Inventory Management is the process of introducing and maintaining an inventory for operational usage in the Organization or releasing new innovative products to the market. The Inventory list must include Systems, Software, Services, Tools, that support the business process with special attention to ‘Patient Safety, Product Quality and Data Integrity’ related to GxP (Good ‘x’ Practices (Laboratory, Manufacturing, Clinical)).
The Inventory list reduces the risk of duplication of systems and provides you with a summary of all the available systems that apply to the quality management system: the current validation status, ownership, impact, system version, and supplier as applicable. Duplication of systems should be avoided. Note: The Inventory Management should be at the level of systems that support business processes.
Tools & Strategies
It is essential that companies look for a system that integrates Inventory Management with the implementation and supporting processes of maintaining a cost-effective system landscape. The combination of processes will serve as an optimal way to keep the Inventory list up-to-date.
If you are currently running numerous of different programs and side projects you will save an enormeous amount of manual efforts by integrating and introducing one single solution as speaking the same language increases competencies, ensures higher awareness, and strengthens collaboration efforts across your business.
Risks and opportunities are important to consider for Inventory Management. Introducing a common harmonized way of documenting and maintaining the inventory also reduces the risk of spending unnecessary resources on sustaining a complex system landscape. You can finally put all of your focus on making the right resources available to motivate and inspire personnel by working with effective processes.
Business & Leadership
Any business owner should prioritize to have an up-to-date inventory list as he/she will have a clear overview of areas where the company could have room-for-improvement (right-sizing). This is also where governance on money, spent on systems in the company, can be established.
Questions such as the following, can easily be justified:
- Why are two Organizations having different systems/tools for the same process?
- How come we are duplicating software licenses?
- What happens if we retire this system?
- Did we implement this solution too fast, as we now are having a lot of operational clean-up activities?
The Business Owner can track the current status of an inventory and determine if the expected resources are accurate or should be modified. Roughly speaking any company owner that is interested in growing a business should be interested in the current status of the Inventory List.
Inventory Management is important in any type of business but is unfortunately not in focus in most companies. However in regulatory companies the tools and strategies of introducing and maintaining inventories are stricter. The level of expected documentation is higher and the sequence of events getting there, are important.
It is preferred that all the company’s inventory is listed. Listing all the regulated inventories is a must.
The Inventory must be categorized, and an assessment must be carried out to determine the (compliance area) Classification.
Companies in regulated industries should always ensure that their computerized systems are compliant and fit-for-intended-use. The systems must be prioritized based on the risk to ‘GxP’ and ‘business criticality’.
The regulatory agencies are not concerned if they have duplicated systems, how they are in use or how many resources are used to maintain them as long as they can demonstrate that the systems are fit-for-intended-use. To avoid this and run an effective and also cost-effective business, Top Management should prioritize having their inventory in order.
Inventory Management Today
Today the Inventory Management is typically kept separate from the processes that are actually maintaining the Inventory. This means that the system owners and the project management must update the list manually as applicable. Either recurrent reviews of the list are established. Sometimes this list is updated when the periodic review is due or consequently, the list is updated at the time an Internal or External Audit is announced.
The inventory list must be updated continuously, and the list should be reviewed regularly. A company can save a lot of money and streamline the business by using the Inventory List as a catalogue of available resources or systems fit-for-intended-use.
The best thing you can do for your business is to get the inventory list displayed on a dashboard with all the implementation and supporting processes. This way the inventory will always be in focus and remind the personnel why they are doing Quality Management. When the Inventory is in control, the periodic reviews of the solutions are easily reported.
Future prospects of Inventory Management
It is my prospects that the future of Inventory Management will entail a lot of ‘hands-off’ compliance work, meaning that the inventory list will always continue to be current, but without manual efforts. Computerized systems will ensure optimal performance on current available systems and report any incident and request before any user will have observed it. The system will possibly be able to report if the system is fit-for-intended-use, and continuously monitor the performance parameters and suggest optimized settings. The systems will create change requests for the updates, which will then be approved by the system owners.